Recall Z-1613-2008 ยท IYE Accelerator, Linear, Medical
Med Tec Inc dba CIVCO Medical Solutions
Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
| Date | May 21, 2008 (initiated Feb 28, 2008) |
| Status | Terminated |
| Reason | Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688. |
| Quantity | 36/3-marker pouches |
| Distribution | Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071614 | FIDUCIAL MARKERS Civco, Sep 11, 2007 |